Lupus Therapeutics and LuCIN Clinical Studies
Lupus Therapeutics has been involved in some of today’s most important breakthroughs in lupus research. And today, we’re helping to guide what we hope will be future breakthroughs.
Lupus Therapeutics and LuCIN Clinical Studies
Lupus Therapeutics has been involved in some of today’s most important breakthroughs in lupus research. And today, we’re helping to guide what we hope will be future breakthroughs.
Lupus Therapeutics and LuCIN Clinical Studies
Lupus Therapeutics has been involved in some of today’s most important breakthroughs in lupus research. And today, we’re helping to guide what we hope will be future breakthroughs.
The Lupus Clinical Investigators Network (LuCIN)
LuCIN is a clinical trials network comprised of 57 of the most reputable academic research medical centers throughout North America. LuCIN brings together the biopharmaceutical industry and academic lupus experts to evaluate the safety and effectiveness of potential new therapies for lupus.
The investigators and other specialized personnel within LuCIN are experts at planning and conducting lupus clinical research on new investigational drugs or repurposed drugs that have already been extensively tested for other diseases and found to be safe.
To learn more about the current portfolio of ongoing clinical trials being conducted within LuCIN as of March 15, 2022, please continue reading below.

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with Active Lupus Nephritis
20 LuCIN sites (U.S. and Canada)
Study Status: Not Yet Recruiting

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
30 LuCIN sites (U.S. and Canada)
Study Status: Not Yet Recruiting

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Two-Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 as a Treatment for Adults With At Least Moderately Active Systemic Lupus Erythematosus
5 LuCIN sites (U.S.)
Study Status: Not Yet Recruiting

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
20 LuCIN sites (U.S. and Canada)
Study Status: Actively Recruiting

A Phase 2 Randomized, Double-Blind, Placebo Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus
7 LuCIN sites (U.S.)
Study Status: Actively Recruiting

A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy
20 LuCIN sites (U.S. and Canada)
Study Status: Actively Recruiting

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
34 LuCIN sites (U.S. and Canada)
Study Status: Actively Recruiting

A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
Study Sponsor: Amgen, Inc.
24 LuCIN sites (U.S. and Canada)
Study Status: Actively Recruiting

Dynamic Imaging of Variation in Lupus Nephritis
7 LuCIN sites (U.S. only)
Study Status: Enrollment Complete

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)
Study Sponsor: EMD Serono
7 LuCIN sites (U.S. only)
Study Status: Completed

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of CC-220 In Subjects With Active Systemic Lupus Erythematosus
23 LuCIN sites (U.S. and Canada)
Study Status: Enrollment Complete

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
Study Status: Completed

A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE)
20 LuCIN sites (U.S. and Canada)
Study Status: Enrollment Complete

A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 With Background Treatment in Subjects With Lupus Nephritis
18 LuCIN Sites (US and Canada)
Study Status: Completed

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
22 LuCIN sites (U.S. and Canada)
Study Status: Enrollment Complete

A Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus Erythematosus
21 LuCIN sites (U.S. only)
Study Status: Completed

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus
9 LuCIN sites (U.S.)
Study Status: Enrollment Complete

Validation of a Mobile Phone Based on EPRO Tool in Subjects With Systemic Lupus Erythematosus
10 LuCIN sites (U.S. and Canada)
Study Status: Completed

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects With Active Lupus Nephritis
8 LuCIN sites (U.S. only)
Study Status: Actively Recruiting

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
15 LuCIN Sites (U.S. and Canada)
Study Status: Actively Recruiting
To learn more about the current portfolio of ongoing clinical trials being conducted within LuCIN as of March 15, 2022, please continue reading below.

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with Active Lupus Nephritis
20 LuCIN sites (U.S. and Canada)
Study Status: Not Yet Recruiting

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
30 LuCIN sites (U.S. and Canada)
Study Status: Not Yet Recruiting

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Two-Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 as a Treatment for Adults With At Least Moderately Active Systemic Lupus Erythematosus
5 LuCIN sites (U.S.)
Study Status: Not Yet Recruiting

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
20 LuCIN sites (U.S. and Canada)
Study Status: Actively Recruiting

A Phase 2 Randomized, Double-Blind, Placebo Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus
7 LuCIN sites (U.S.)
Study Status: Actively Recruiting

A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy
20 LuCIN sites (U.S. and Canada)
Study Status: Actively Recruiting

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
34 LuCIN sites (U.S. and Canada)
Study Status: Actively Recruiting

A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
Study Sponsor: Amgen, Inc.
24 LuCIN sites (U.S. and Canada)
Study Status: Actively Recruiting

Dynamic Imaging of Variation in Lupus Nephritis
7 LuCIN sites (U.S. only)
Study Status: Enrollment Complete

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)
Study Sponsor: EMD Serono
7 LuCIN sites (U.S. only)
Study Status: Completed

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of CC-220 In Subjects With Active Systemic Lupus Erythematosus
23 LuCIN sites (U.S. and Canada)
Study Status: Enrollment Complete

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
Study Status: Completed

A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE)
20 LuCIN sites (U.S. and Canada)
Study Status: Enrollment Complete

A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 With Background Treatment in Subjects With Lupus Nephritis
18 LuCIN Sites (US and Canada)
Study Status: Completed

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
22 LuCIN sites (U.S. and Canada)
Study Status: Enrollment Complete

A Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus Erythematosus
21 LuCIN sites (U.S. only)
Study Status: Completed

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus
9 LuCIN sites (U.S.)
Study Status: Enrollment Complete

Validation of a Mobile Phone Based on EPRO Tool in Subjects With Systemic Lupus Erythematosus
10 LuCIN sites (U.S. and Canada)
Study Status: Completed

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects With Active Lupus Nephritis
8 LuCIN sites (U.S. only)
Study Status: Actively Recruiting

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
15 LuCIN Sites (U.S. and Canada)
Study Status: Actively Recruiting